Kornimate/medical-research-clean huggingface dataset:
family oriented mindfulness informed legal education (famile) programme for parent or carers affected by incarceration and improving parenting in nigeria

Conditions: Trauma; Depression; Anxiety; Parenting Intervention

Summary: incarceration is a prevalent problem globally and in nigeria. its effect significantly impacts left behind parent or primary care givers and also the wellbeing of the families and children. limited access to support has posed a constraint in effectively addressing the issues suffered by affected families in nigeria. in addition, having a family member incarcerated could affect parenting due to factors such as anxiety, trauma, depression, poor social support, awareness of legal channels for complaint and harsh parenting to children. the implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to children\&#39;s development and wellbeing and resort to criminal behaviours. in essence this study seeks to examine the feasibility and acceptability of a brief family oriented mindfulness informed legal education (famile) intervention in comparison to the waitlist control group (who will be administered the intervention at a later date) in improving parenting, legal awareness, social cohesion, wellbeing and reducing trauma and anxiety as a result of the effect of having a family member incarcerated.


Eligibility criteria:
inclusion criteria: * 18 years and above * parent or carer with child(ren) or with caring responsibilities for children affected by incarceration. * able to provide full consent for their participation. * a resident of the study areas (delta, jos or lagos state) exclusion criteria: * less than 18 years * unable to consent * currently undergoing severe mental health treatment * unable to speak the english language fluently

Keywords: parenting intervention anxiety incarceration family depression truama
effect of external cold and vibration (buzzy device) versus the conventional technique on pain perception during local anesthesia injection in children.

Conditions: Anesthesia; Anesthesia, Local; Vibration

Summary: this study adopts the null hypothesis (there is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

the injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. there is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.the efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. the evaluation the pain perception and comfort of the patient during local anesthesia delivery using the buzzy device and conventional syringe and revealed that the external cold and vibration via buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Eligibility criteria:
inclusion criteria: * children classified as cooperative or potentially cooperative according to wright's classification of child behaviour. * medically fit children (asa i, ii). * children mentally capable of communication. * children aged 6-11 years. * first dental visit. * patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment. exclusion criteria: * children with a behavioral management problem. * children with known allergy to local anesthetic agents. * parental refusal for participation
an efficacy and safety study of oral azacitidine (cc-486) as maintenance therapy in chinese participants with acute myeloid leukemia in complete remission

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study is to evaluate the efficacy and safety of oral azacitidine (cc-486) in chinese participants with acute myeloid leukemia in complete remission.


Eligibility criteria:
inclusion criteria: * newly diagnosed, histologically confirmed de novo acute myeloid leukemia (aml) or aml secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (cmml) * eastern cooperative oncology group performance status of 0, 1, or 2 * has undergone induction therapy with intensive chemotherapy with or without consolidation therapy * must have achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) status within 6 months (+/- 7 days) prior to starting study therapy exclusion criteria: * suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia * candidate for allogeneic bone marrow or stem cell transplant at screening * have achieved cr/cri following therapy with hypomethylating agents * aml associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations * proven central nervous system leukemia * prior bone marrow or stem cell transplantation other protocol-defined inclusion/exclusion criteria apply

Keywords: azacitidine cc-486 onureg acute myeloid leukemia
study of viral load and maternal-fetal serology in the interpretation of the vertical transmission of sars cov-2 (covid-19) during pregnancy

Conditions: Sars-CoV2

Summary: the study evaluates the distribution of immunological and virological profiles of newborns patients. mothers of these children have a proven infection to sars cov-2 during pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant woman * diagnosed with sars cov-2 during pregnancy * singleton or twin pregnancy * informed consent exclusion criteria: * virological or serological samples not done the day of delivery
anterior cruciate ligament injury prevention protocol in female football players with dynamic knee valgus

Conditions: Anterior Cruciate Ligament Injuries

Summary: introduction: women's football has experienced exponential growth over the last ten years. its popularity is associated with an increase in anterior cruciate ligament injuries (acl). they constitute a major current problem as they account for 43% of the injury burden during the sport season. despite existing training programmes, no uniform criteria have been established to design a precise intervention protocol, with specific tasks linked to women's football, nor has it been proposed to optimise current programmes. objective: to evaluate the efficacy of a comprehensive and specific training protocol focused on female football players with dynamic knee valgus (dkv) to prevent acl injuries. methodology: randomised, double-blind, single-centre clinical trial protocol scheduled for the 2023-2024 season of women's football. there will be 2 groups: a group that will follow a specific acl injury prevention protocol and a control group. the intervention period will last 12 weeks. measurements will be taken at 3 time points. the biomechanics of the lower extremities, the dynamics of jumping and landing, as well as the pre and post training satisfaction of the players will be evaluated. image capture and processing systems will be used in addition to tests such as the drop vertical jump test (dvj), the less scoring system, among others. future expectations: this protocol aims to be one of the first to implement an acl injury prevention programme for women football players with dkv. despite the scarcity of research in this area, studies support beneficial effects at a preventive level.


Eligibility criteria:
inclusion criteria: * female football players registered and federated in the corresponding team. * with an age range between 18 and 35 years old. * minimum experience of one year playing football. * with dkv presence. exclusion criteria: * subjects with previous acl or other ligamentous injury to the knee. * subjects with a history of lower extremity injury resulting in surgery during the six months prior to the study. * players with chronic illnesses that may affect test results. * subjects who played other sports at a professional level.

Keywords: knee injuries female football
immune status after being on call for 24 hrs

Conditions: Sleep Deprivation

Summary: sleep deprivation is a prevalent problem in modern societies. sleep deprivation can cause hormonal changes, such as an increase in cortisol, as well as inflammation. animal studies have shown an increase in inflammatory cytokine production following sleep deprivation. additionally, humans experiencing sleep deprivation may experience a decrease in natural killer cells and lymphocytes. physicians, particularly those in surgical specialties, are often subjected to sleep deprivation as part of their medical residency training. this study hypothesizes that after 24-hour shifts, there is an increase in inflammatory response and impairment of the immune response against unspecific activation. this proposal aims to provide insight into the impact of sleep deprivation on the immune system of surgery residents by characterizing the phenotype and function of immune cells, as well as their correlation with biometric data.


Eligibility criteria:
inclusion criteria: * healthy subjects * surgery residents in a 24-hour shift rotation * gender of subjects: males and females * age of subjects: 18 years old and older * racial and ethnic origin: any race or ethnicity exclusion criteria: * unwilling/unable to sign informed consent * vulnerable subjects/subject capacity to provide consent
effect of intra-cuff lidocaine and tetracaine on tracheal tube-induced emergence phenomena

Conditions: Pharyngitis

Summary: it has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. in the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.

the female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. the cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the minimal occlusive volume technique. this was done by the same anaesthesiologist in all the patients. the cuff volume and pressure were then recorded. the primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. the secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. net volume of the inflation medium was noted. volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. incidence (yes/no) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.

Eligibility criteria:
inclusion criteria: * patients of the age group 18-60 years * patients belonging to asa grade i and ii undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using poly vinyl chloride ett (same type and make in all patients) exclusion criteria: * anticipated difficult intubation * more than one attempt for intubation * need for naso gastric tube * episode of coughing and straining * history of respiratory tract infection and smoking

Keywords: lidocaine tetracaine tracheal intubation pharyngitis
long-term treatment study of certolizumab pegol (cdp870) as add-on medication to methotrexate in japanese rheumatoid arthritis (ra) patients

Conditions: Rheumatoid Arthritis

Summary: the objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in japanese ra patients transferred from study 275-08-001 (nct00791999), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in american college of rheumatology 20% (acr20) responders who completed study 275-08-001.

this study was initiated by otsuka pharmaceutical co., ltd and transferred to astellas on 12/04/2012.

Eligibility criteria:
inclusion criteria: * subjects who participated in study 275-08-001 and meet all of the criteria described below. * patients who did not reach acr20, and prematurely discontinued study 275-08-001 at week 16 or completed study 275-08-001 by week 24. * patients who are able to receive treatment with mtx, by week 52. exclusion criteria: * patients who experienced an important protocol deviation as mentioned below during study 275-08-001. * patients who received live or attenuated vaccines during study 275-08-001(except for influenza or pneumococcal vaccines). * patients who were found to have tuberculosis on a chest x-ray during study 275-08-001. * patients who required treatment for the same infection at two or more different times during study 275-08-001 * women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months. * patients whom the investigator has decided to be inappropriate for participation in the study

Keywords: rheumatoid arthritis certolizumab pegol cimzia
the efficacy of vocal function exercises for laryngeal cancers

Conditions: Vocal Folds

Summary: the purpose of this study is to determine if the systematic practice of vocal function exercises (vfe) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. it is hypothesized that a prescriptive vocal exercise program (vfe) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.


Eligibility criteria:
inclusion criteria: * hearing level and cognitive ability to follow test directions * laryngeal cancer * radiation therapy completed \>= 6 months * deemed disease free by the treating physician * subjects have to be willing to attend weekly voice therapy sessions exclusion criteria: * adjuvant treatment: laser or any surgical intervention * neurological or cognitive impairment * hearing levels that interfere with following test instruction * vocal fold paralysis

Keywords: radiation therapy, laryngeal cancer, voice therapy, vocal function exercises
observational study of clinical performance of a sterile, bacteria-binding, super-absorbent wound dressing

Conditions: Wounds

Summary: this prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years old * written informed consent after patient education to participate in the study * superficial wounds of any etiology affecting only epidermis and dermis layers * maximum wound size: 6 x 16cm / 6 x 6cm * wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following: * wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or * wounds with one or more historical episodes of topical infection and/or * wounds assessed as at a high risk of infection on other grounds by the investigator. * superficial wounds with high levels of exudate exclusion criteria: * not willing to sign or incapable of signing an informed consent form * known allergy or sensitivity to one of the dressing components * pregnancy or lactation * subject is participating in another clinical study
nutrigenomics diet intervention study comparing effects of western and balanced diet in healthy subjects

Conditions: Cardiovascular Diseases; Chronic Disease

Summary: diet macronutrient relative composition, quality and quantity determines lifestyle disease, including cardiovascular disease, development. our hypothesis is that a high content of carbohydrates in the diet contributes to increased insulin level. moreover, activating enzymes promoting inflammatory processes and possibly chronic disease development in the body.

the most frequent cause of death in both women and men in the western world is cardiovascular artery disease (cad). well accepted as a lifestyle disease, known risk factors for cad development include changes in blood lipid content and type as well as micro inflammation in the arterial wall. low density lipoprotein (ldl) and triglycerides are increased, high density lipoprotein (hdl) is reduced. furthermore, type ii diabetes, metabolic syndrome, hypertension, overweight, reduced physical activity and smoking also precede cad development. common for many of the risk factors is that they are induced by improper diet. recent research has shown that especially total amount, composition and quality of the macro nutrients, protein, carbohydrate and fats, is important. in this project we will explore changes in blood gene expression in response to a western and a balanced crossover diet intervention.

Eligibility criteria:
inclusion criteria: * healthy * bmi 24.5-27.5 * pass health check criteria exclusion criteria: * chronic diseases * inflammation * pregnancy and lactation

Keywords: nutrigenomics gene expression diet, carbohydrate-restricted life style health behavior
clinical evaluation of the 'exodx prostate intelliscore' (epi)

Conditions: Cancer of Prostate

Summary: the purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy the current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).

primary objective(s) * confirm performance of the exodx prostate (intelliscore) (epi) utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/ml). * evaluate impact of the confirmed exodx prostate (intelliscore) on the decision to perform an initial prostate biopsy for men presenting with an elevated prostate-specific antigen (2-10 ng/ml). secondary and exploratory objectives * assess physician satisfaction with the exointelliscore prostate report including test result presentation, graphics and interpretation. * assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy. * determine the medical economic impact of the exointelliscore prostate in the prostate biopsy decision process. * correlation of the exointelliscore prostate score with the actual biopsy result.

Eligibility criteria:
inclusion criteria: * 50 years of age * clinical suspicion for prostate cancer * elevated prostate-specific antigen between: 2.0 - 10 ng/ ml * no clinical history of a prior negative biopsy exclusion criteria: * history of prior prostate biopsy. * use of medications or hormones that are known to affect serum prostate-specific antigen levels within 3-6 months of study enrollment. * clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. * history of prostate cancer. * history of invasive treatments for benign prostatic hypertrophy (benign prostatic hyperplasia) or lower urinary track symptoms within 6 months of study enrollment. * no known hepatitis (all types) and/or hiv documented in patient's medical record. * patients with history of concurrent renal/bladder tumors.
negative pressure wound therapy for prevention of poststernotomy infection

Conditions: Surgical Wound Infection

Summary: this prospective study evaluates the role of negative pressure wound therapy or wound vac as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. vacuum assisted closure (vac) has been used in the management of open and infected wounds. however, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Eligibility criteria:
inclusion criteria: 1. transplant patients 2. bmi \>30 3. type i (insulin-dependent) diabetics 4. severe chronic obstructive pulmonary disease (copd) 5. steroid-dependent patients 6. previous tracheostomy exclusion criteria: 1. bmi\<30 2. thoracotomy
a study to compare severe asthma patients who start biologics and who do not start (prospect)

Conditions: Asthma

Summary: objectives in this study is to compare the change of lung function after 24 months from baseline between the two groups; one is the patient group who decided to start biologics treatment, and another is the patient group who decided to start non-biologics treatment. the target patients are the adult uncontrolled severe asthma patients.


Eligibility criteria:
inclusion criteria: 1. confirmed asthma diagnosis 2. using high-dose icsa and 2nd controllerb more than 3 months before registration 3. uncontrolled asthma which constitutes one or more of 1) poor symptom control: acq-5≧1.5 or atc\<20 2) frequent exacerbations: at least 2 asthma exacerbations in the 12 months prior to the registration 3) airflow obstruction: fev1 before taking bronchodilator \<80% predicted (fev1/fvc less than the lower limit of normal) c 4. investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators. 5. patients deemed capable of visiting their study site next 24 months regularly 6. patients from whom written consent to participate in this study has been obtained 7. patients≧20 years old at obtaining consent exclusion criteria: 1. participated in other interventional studies such as clinical trials, etc within the last 8 weeks. 2. are using biologics at registration 3. diagnosed as copd 4. plan the bt therapy near future 5. receipt of any marketed or investigational biologics within 5 months before the registration 6. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: * affect the safety of the patient throughout the study * influence the findings of the studies or their interpretations * impede the patient's ability to complete the entire duration of study.